For patient care, a monitor or alerting device should be a critical component where oxygen tubing is used with a flow regulator and where a concern exists that the tubing can become disconnected, thus interrupting oxygen flow to the patient. Until now, such a device has not existed. This need for an alerting device can occur where tubing is connected to a gas supply through a flow regulator, and eventually to a nasal prong or face mask, such as in hospital rooms, nursing homes, outpatient and convalescent facilities, doctor's offices, diagnostic and procedure rooms, operating rooms, and private homes. In many situations, a barbed nipple, sometimes combined with a nut adapter (and also commonly referred to as a barbed nipple adapter or Christmas tree adapter), is attached to a flow regulator combined with a source of oxygen. Then, tubing runs from the barbed nipple to the patient's nasal cannula or facemask. Unfortunately, in these situations there is no warning device to alert medical personnel, or anyone looking after the patient, that the tubing has become disconnected from the barbed nipple and that a gas is flowing freely into the ambient air.
There are many potentially serious consequences of oxygen flowing through a barbed nipple adapter with the tubing disconnected. Most serious are the consequences of a patient not receiving oxygen. Medical personnel may not be aware of or alerted to that situation, believing a patient is receiving oxygen when in fact he is not. The same issue arises when a patient is responsible for administering and monitoring his own oxygen. Without an adequate supply of oxygen, the body's cells can stop functioning. Consequently, the patient can suffer hypoxia, stroke, brain damage, paralysis, poor wound healing, or other grave problems while medical personnel incorrectly believe the patient is receiving oxygen. This situation also wastes oxygen, an expensive and critical medical resource, and heightens the combustibility and flammability of the oxygen-enriched environment around the patient.
Safety and monitoring are becoming increasingly important in every aspect of clinical practice. Evidence is accumulating that clinical and hospital errors of all types are a far greater cause of morbidity and death than the medical profession has previously realized. Tracing individual outcomes back to their cause is not always possible, and even when it is, the medical profession is obligated to address both known and reasonably anticipated problems. Therefore, every aspect of clinical care must be scrutinized for safety, potentially deleterious effects, and the possibility of improvement. There has been a long-felt need to quickly identify when an oxygen tubing line has become disconnected from the oxygen source for the patient, because of its potentially fatal consequences. For decades, medical personnel have expressed their frustration with this problem. A solution would save medical resources and money, and, even more importantly, decrease preventable morbidity and mortality, i.e., prevent adverse unfavorable medical events and save lives.